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Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer

Primary Purpose

Bladder Cancer, Gemcitabine and Cisplatin Chemotherapy, Epirubicin Instillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gemcitabine, cisplatin
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. moderate-high risk non-muscle invasive bladder cancer patients: Multiple,recurrent, II-III grade, tumor diameter>3cm, invasive to submucosa, associated with carcinoma in situ.
  2. Normal liver and renal function.

Exclusion Criteria:

  1. Liver and renal function deficiency (GFR<60ml/min*kg, ALT、AST>1.5*normal), lung function deficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension and anaerobic conditions.
  2. Attending other drug experiments.
  3. Performance status, Zubrod-ECOG-WHO, ZPS≥2.
  4. Pregnant.
  5. Bone marrow transplantation, severe leukopenia, associated with severe infection or injury.

Sites / Locations

  • The first affiliated hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Monotherapy

Combination

Arm Description

Barely epirubicin was instilled after TURBT. Epirubicin was immediately instilled in 24h after TURBT. Instillation was conducted regularly for a year: once in a week for 8 times, once in two weeks for 8 times, once in a month for 6 times.

Patients who were pathologically confirmed as moderate-high risk NMIBC. Epirubicin was immediately instilled in 24h after TURBT and regularly conducted for a year. Intervention: GC scheme systematic chemotherapy was underwent 5 days after TURBT, which contained gemcitabine 1000-1200mg/m2. Cisplatin (70mg/m2) was intravenous dripped in the first and 8th day after TURBT. Intravenous rehydration was conducted in the second day.

Outcomes

Primary Outcome Measures

Tumor progression
Drug intervention complications
WBC and PLT decreasing, impaired liver function, nausea and vomiting

Secondary Outcome Measures

The percent of patients transferred to radical cystectomy.
The existence of circulating tumor cells.

Full Information

First Posted
March 14, 2016
Last Updated
March 22, 2016
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02716961
Brief Title
Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
Official Title
Prospective Cohort Study of Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy to Prevent Moderate-high Recurrence and Progression Risks of Muscle-invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

5. Study Description

Brief Summary
It is still a challenge for urologic surgeon to prevent the post transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. It is common to observe clinically moderate-high risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC.
Detailed Description
Prevention of the post-transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder cancer(NMIBC) is still a difficult problem. NMIBC was classified as low, moderate and high risk patients. Moderate-high risk NMIBC contained those are multiple, recurrent, II-III grade, tumor diameter >3cm, invasive to submucosa and associated with carcinoma in situ. For those patients, no matter which treatment was conducted, for example, exchanging instillation drugs, increasing medicine dose, appending adjuvant drugs and prolonging instillation time, would not improve the prognosis of these patients. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. For muscle invasive bladder cancer patients, radical cystectomy with neoadjuvant chemotherapy will improve patients' tumor grade and increase overall survival and disease specific survival rate.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC. In addition, we also would like to investigate the improvement of life quality after TURBT of moderate-high risk NMIBC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Gemcitabine and Cisplatin Chemotherapy, Epirubicin Instillation, Recurrence, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy
Arm Type
No Intervention
Arm Description
Barely epirubicin was instilled after TURBT. Epirubicin was immediately instilled in 24h after TURBT. Instillation was conducted regularly for a year: once in a week for 8 times, once in two weeks for 8 times, once in a month for 6 times.
Arm Title
Combination
Arm Type
Experimental
Arm Description
Patients who were pathologically confirmed as moderate-high risk NMIBC. Epirubicin was immediately instilled in 24h after TURBT and regularly conducted for a year. Intervention: GC scheme systematic chemotherapy was underwent 5 days after TURBT, which contained gemcitabine 1000-1200mg/m2. Cisplatin (70mg/m2) was intravenous dripped in the first and 8th day after TURBT. Intravenous rehydration was conducted in the second day.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, cisplatin
Other Intervention Name(s)
Combination
Intervention Description
Patients who were pathologically confirmed as moderate-high risk NMIBC. Epirubicin was immediately instilled in 24h after TURBT and regularly conducted for a year. GC scheme systematic chemotherapy was underwent 5 days after TURBT, which contained gemcitabine 1000-1200mg/m2. Cisplatin (70mg/m2) was intravenous dripped in the first and 8th day after TURBT. Intravenous rehydration was conducted in the second day.
Primary Outcome Measure Information:
Title
Tumor progression
Time Frame
Changes from post-chemotherapy to 5 years
Title
Drug intervention complications
Description
WBC and PLT decreasing, impaired liver function, nausea and vomiting
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The percent of patients transferred to radical cystectomy.
Time Frame
Up to 5 years
Title
The existence of circulating tumor cells.
Time Frame
Before and 4 months after TURBT.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate-high risk non-muscle invasive bladder cancer patients: Multiple,recurrent, II-III grade, tumor diameter>3cm, invasive to submucosa, associated with carcinoma in situ. Normal liver and renal function. Exclusion Criteria: Liver and renal function deficiency (GFR<60ml/min*kg, ALT、AST>1.5*normal), lung function deficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension and anaerobic conditions. Attending other drug experiments. Performance status, Zubrod-ECOG-WHO, ZPS≥2. Pregnant. Bone marrow transplantation, severe leukopenia, associated with severe infection or injury.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Lu, PhD
Phone
13505196501
Email
dxhlvqiang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengchao Li, PhD
Phone
13584025756
Email
superkulian@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Lu, PhD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Lu, PhD
Phone
13505196501
Email
dxhlvqiang@163.com
First Name & Middle Initial & Last Name & Degree
Pengchao Li, PhD
Phone
13584025756
Email
superkulian@aliyun.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21458150
Citation
Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Bohle A, Palou-Redorta J, Roupret M; European Association of Urology (EAU). EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2011 update. Eur Urol. 2011 Jun;59(6):997-1008. doi: 10.1016/j.eururo.2011.03.017. Epub 2011 Mar 22.
Results Reference
result
PubMed Identifier
26091833
Citation
Sylvester RJ, Oosterlinck W, Holmang S, Sydes MR, Birtle A, Gudjonsson S, De Nunzio C, Okamura K, Kaasinen E, Solsona E, Ali-El-Dein B, Tatar CA, Inman BA, N'Dow J, Oddens JR, Babjuk M. Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa-pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation? Eur Urol. 2016 Feb;69(2):231-44. doi: 10.1016/j.eururo.2015.05.050. Epub 2015 Jun 16.
Results Reference
result
PubMed Identifier
20689253
Citation
Villavicencio H, Rodriguez Faba O, Palou J, Gausa L, Algaba F, Marcuello E. Bladder preservation strategy based on combined therapy in patients with muscle-invasive bladder cancer: management and results at long-term follow-up. Urol Int. 2010;85(3):281-6. doi: 10.1159/000316076. Epub 2010 Jul 30.
Results Reference
result

Learn more about this trial

Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer

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